Monday, July 20, 2015

Jenna DeCurzio @ Albert Einstein College of Medicine

On Conflicts of Interest and Traversing the Pathway of Scientific Careers

“How much are you really going to learn in one week?” one of my friends asked me before I left, speaking of their experiences from a long internship. Unsure myself, I thought to all of the preparatory work I was required to complete before my externship, answer coming easily. “A lot.” Those two words, a lot, cannot begin to describe the amount of information I learned during my week long externship at Albert Einstein College of Medicine of Yeshiva University with Dr. Michael Reichgott, who is the Chair of Einstein’s Institutional Review Board (IRB) and Conflict of Interest (COI) Committee. The experience was an enlightening one, as it not only gifted me with knowledge of the intellectual kind, but also of the personal kind, guiding me towards the path I would like to see myself walk down in the future.

The purpose of the COI Committee is to review investigators’ disclosures to ensure that the investigators’ financial interests do not conflict with their academic responsibilities… in particular research and teaching. The committee also reviews other possible sources of conflict of interest, such as personal conflicts of interest that can be caused by religion or personal beliefs. The IRB’s purpose is the protection of human study participants. Both processes are policed by federal regulations, though the institution is at liberty to make them more stringent, though never less. While research is significant in the advancement of general knowledge and the well-being of individuals of all kinds, it is important to reach it in a fair, statistically significant, and ethically-sound manner, which is in large part why the COI Committee and the IRB are so important.

There are several levels of IRB review: exempt, expedited, and full board, each corresponding to a different level of risk. Exempt reviews pertain to protocols that will cause less than minimum risk, while expedited are protocols that will cause minimum risk. Both exempt and expedited protocols can be reviewed and accepted by one member of the IRB. Exempt protocols can involve an educational setting or a survey of some sort, though there are a total of six categories that an exempt review can fall under. There are nine possible categories for expedited reviews which sometimes involve processes that can be completed at a routine doctor’s appointment, such as drawing blood (though no more than a certain amount dependent upon who the blood is being drawn from. Full board reviews are for protocols that exhibit greater than minimum risk and do not fall under either category. Therefore, it must undergo a more thorough discussion and analyzation.

Drugs must undergo phases of testing in order to be released into the public market. However, as I learned from Urvashi Arora, an Administrator of the IRB on Einstein’s West Campus, there are situations in which a drug is capable of bypassing one or more phases: emergency use and compassionate use. As the name suggests, emergency use is the use of a drug in a situation where there is either no known cure, the known cures are not working, and there is a state of emergency. The drug must have pre-existing results from testing that indicates a positive effect and the protocol must still pass through an IRB. Compassionate use is a case in which the disease being treated only effects a small population of individuals. The small population must be proved in order to advocate the case.

During the week, I was given the amazing opportunity to attend an IRB meeting. Confidentiality is a large part of the IRB, whether it be in regards to the meetings or the identity of research participants. It was a great experience to witness, first-hand, the delegations that occur within a meeting. Learning a concept with an example is helpful, though pales in comparison to actually hearing discussions and witnessing the process occur. Not all protocol are presented to the board, as exempt and expedited cases can be passed with the signature of one IRB member. Exempt and expedited cases are protocols which present less than minimum risk or minimum risk and fall within certain categories.

My week at Einstein was spent speaking to employees involved with either the COI Committee, IRB, or both. They were lovely and patient as I struggled to understand their roles, vocabulary, and the legal concepts that come rather easily to them. I was also given the excellent opportunity to speak to faculty, learning more about their research and their role(s) in the school and community. With every person I spoke to, I received a better idea of what I would like to do once I graduate from Gettysburg College. However, as every person I spoke to told me, I am still young and there is still time left to understand myself and my options better. And they are right – I am still young, and there is still time until I have to truly decide. All the same, it is empowering and refreshing to leave Albert Einstein with a better idea of the career path I would like to walk and what exactly goes on in the protocol approval process. So, how much can you learn in a week…? A lot. And you can never know too much!